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    Two years later, Lilly ICOS, LLC, filed a new drug application with the FDA for compound IC351 (under the tadalafil generic name, and the Cialis brand name).

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    It initially was developed by the biotechnology company ICOS , and then again developed and marketed worldwide by Lilly ICOS, LLC, the joint venture of ICOS Corporation and Eli Lilly and Company . Cialis tablets, in 2.5 mg, 5 mg, 10 mg, and 20 mg doses, are yellow, film-coated, and almond-shaped.
    The approved dose for pulmonary arterial hypertension is 40 mg (two 20 mg tablets) once daily.
    Tadalafil is also manufactured and sold under the name of Tadacip by the Indian pharmaceutical company Cipla in doses of 10 mg and 20 mg.
    Cialis is also offered as a once-daily medication.
    Tadalafil was approved in May 2009 in the United States for the treatment of pulmonary arterial hypertension and is under regulatory review in other regions for this condition.
    Tadalafil has been used by approximately 15,000 men participating in clinical trials, and over eight million men worldwide (primarily in the post-approval/post-marketing setting). The most common side effects when using tadalafil are headache , stomach discomfort or pain, indigestion, burping , acid reflux, back pain , muscle aches , flushing , and stuffy or runny nose . These side effects reflect the ability of PDE5 inhibition to cause vasodilation (cause blood vessels to widen), and usually go away after a few hours.
    In May 2005, the U.S. Food and Drug Administration found that tadalafil (along with other PDE5 inhibitors) was associated with vision impairment related to NAION ( non-arteritic anterior ischemic optic neuropathy ) in certain patients taking these drugs in the post-marketing (outside of clinical trials) setting.
    Most, but not all, of these patients had underlying anatomic or vascular risk factors for development of NAION unrelated to PDE5 use, including: low cup to disc ratio ("crowded disc"), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia and smoking.

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    Given the small number of NAION events with PDE5 use (fewer than one in one million), the large number of users of PDE5 inhibitors (millions) and the fact that this event occurs in a similar population to those who do not take these medicines, the FDA concluded that they were not able to draw a cause and effect relationship, given these patients underlying vascular risk factors or anatomical defects.
    However, the label of all three PDE5 inhibitors was changed to alert clinicians to a possible association.
    In October 2007, the FDA announced that the labeling for all PDE5 inhibitors, including tadalafil, requires a more prominent warning of the potential risk of sudden hearing loss as the result of postmarketing reports of deafness associated with use of PDE5 inhibitors.
    Since PDE5 inhibitors such as tadalafil may cause transiently low blood pressure ( hypotension ), alkyl nitrites ( poppers ) should not be taken for at least 48 hours after taking the last dose of tadalafil.
    Using poppers (such as the sex drug amyl nitrite ) within this timeframe may increase the risk of life-threatening hypotension.
    Since people who have taken tadalafil within the past 48 hours cannot take organic nitrates to relieve angina (such as glyceryl trinitrate spray), these patients should seek immediate medical attention if they experience anginal chest pain.
    In the event of a medical emergency, paramedics and medical personnel should be notified of any recent doses of tadalafil.
    Tadalafil is metabolized predominantly by the hepatic CYP3A4 enzyme system.
    The presence of other drugs which induce this system can shorten tadalafil half-life and reduce serum levels, and hence efficacy, of the drug.

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